This randomized controlled study in patients with post-stroke dysphagia aims to determine the optimal stimulation frequency of electroacupuncture of the suprahyoid muscles and to elucidate the underlying neural mechanisms. Participants will be assigned to low-frequency (2 Hz), medium-frequency (50 Hz), or high-frequency (100 Hz) electroacupuncture groups. Therapeutic efficacy will be assessed using the Kubota water-drinking test, videofluoroscopic swallowing study (VFSS), and ultrasonography to identify the optimal frequency. In parallel, diffusion tensor imaging (DTI) will be used to evaluate changes in fiber connectivity between swallowing-related cortical regions (bilateral precentral gyrus, insula, supramarginal gyrus, and frontal lobe) and the medullary nucleus tractus solitarius, thereby exploring neural network remodeling and providing mechanistic evidence to inform clinical practice.
Diagnosis: Patients diagnosed with cerebral infarction confirmed by CT or MRI.
Dysphagia Screening: Presence of varying degrees of dysphagia as screened by the Water Swallow Test (WST).
Clinical Status: Conscious and stable vital signs, with the ability to cooperate with the treatment.
Age: Aged between 18 and 80 years.
Dysphagia Etiology: Patients with dysphagia caused by etiologies other than cerebral infarction.
MRI Contraindications: Patients with metal implants or pacemakers in the body (contraindications for MRI).
Bleeding Risk: Patients with bleeding tendencies or coagulation disorders.
Blood Pressure: Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 120 mmHg).
Parallel
Low Frequency EA
DeviceElectroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 2 Hz (Low Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Medium Frequency EA
DeviceElectroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 50 Hz (Medium Frequency). The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
High Frequency EA
DeviceElectroacupuncture will be applied to the suprahyoid muscles. The stimulation frequency will be set at 100 Hz (High Frequency).The intensity should be adjusted to the patient's tolerance, utilizing a discontinuous waveform. Treatment is administered once daily for 30 minutes, with a course cosisting of 7 sessions. A rest day is observed between courses, and the treatment is continued for a total of 6 courses.
Change in Water Swallow Test (WST) Score
The WST is a screening tool for dysphagia. It assesses the ability to swallow water and the presence of coughing or choking. Scores range from 1 to 5, with higher scores indicating more severe dysphagia. Improvement is defined as a decrease in the WST score.
Change in Penetration-Aspiration Scale (PAS) Score via VFSS
The PAS is an 8-point scale used to describe the severity of penetration and aspiration events during a Videofluoroscopic Swallowing Study (VFSS). Lower scores indicate safer swallowing function.
Hyolaryngeal excursion measured by Ultrasound
B-mode ultrasound will be used to measure the anterior and superior displacement distance of the hyoid bone and larynx during swallowing. Greater displacement indicates better function of the suprahyoid muscles.
Changes in Fractional Anisotropy (FA) values of swallowing-related neural pathways
Diffusion Tensor Imaging (DTI) will be used to measure the Fractional Anisotropy (FA) values of white matter fiber tracts connecting the bilateral precentral gyrus, insula, supramarginal gyrus, frontal lobe, and the nucleus of the solitary tract. Higher FA values indicate better structural integrity of the neural network.
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Kaili Chen
Lead sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor institution
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